Rapid Dipstick Test for Detection of phIGFBP-1 in Cervical Secretion as Pre-Term Birth Risk Factor - India CDSCO Medical Device Registration
Rapid Dipstick Test for Detection of phIGFBP-1 in Cervical Secretion as Pre-Term Birth Risk Factor is a medical device registered with India's Central Drugs Standard Control Organization (CDSCO) under UID MFG/MD/2020/000208_dbd45e732a89c1580905f65627f4ce0f_df4e4bbced3e4acc3753501d48b2ac86. This device is marketed under the brand name EzDx Actim Partus . The license holder is ADVY CHEMICAL PVT. LTD., and it is classified as Device Class Class B. The approving authority is Kokan Division.
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Brand Name
EzDx Actim Partus
License Holder
ADVY CHEMICAL PVT. LTD.Device Class
Approving Authority
Kokan Division
Product Information
Actim Partus is a visually interpreted, qualitative immunochromatographic dipstick test for detecting the presence of phosphorylated IGFBP-1 (EzDx Actim Partus ) in cervical secretions during pregnancy. The test is intended for professional use to help predict the risk of preterm or imminent delivery when fetal membranes are intact. A negative test result is a clear indication that the patient will not deliver within 7-14 days
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